Skin Neoplasms Clinical Trial
Official title:
A Pilot Trial of Polypodium Leucotomos in Preventing Skin Cancer and Its Precursors
NCT number | NCT02813902 |
Other study ID # | 2016P001176 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | July 2019 |
Est. completion date | May 2020 |
Verified date | March 2019 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This proposal describes a pilot study to gather preliminary evidence of efficacy, tolerability and toxicity of oral PLE among a high-risk skin cancer population for the prevention of Actinic keratosis (AKs) and keratinocytes (KCs) to gain insight into optimal methods for recruitment, intervention development, data collection, and promoting protocol adherence prior to conducting a fully powered trial. The primary clinical outcome is AKs as measured by a clinical dermatologist, with skin cancer as a secondary clinical outcome. The investigators will also assess histologic markers of Ultra Violet (UV) damage, which have previously been shown to be reduced with oral PLE use in human studies, namely formation of UV-induced cyclo pyrimidine dimer positive cells and number of sunburn cells among epidermal keratinocytes. Results generated from this proposal will form the foundation of a fully powered clinical trial of the effect of PLE on the risk of AKs and KCs. The results may also provide information about this promising dietary supplement which may provide extra protection for a high-risk skin cancer population.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 2020 |
Est. primary completion date | May 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Must be male or female and at least 18 years of age. - Female patients must be of: - Non-childbearing potential; - Childbearing potential, provided negative urine pregnancy test and using effective contraception. - Dermatologist-rendered diagnosis of AK in the past 2 years. Exclusion Criteria: - History of >2 skin cancers in the past 5 years - History of dementia - Cardiovascular disease, defined as Blood Pressure (BP) <90/60 or Heart rate (HR) >110 in the past year or a history of myocardial infection - Inflammatory bowel disease/irritable bowel syndrome - Treatment with Fluorouracil, imiquimod, diclofenac, or photodynamic therapy in the past 8 weeks - Intention to seek more aggressive AK therapy such as photodynamic therapy, laser surgery in next 12 months - Serious psychological illness - History of alcohol or drug abuse - Any disease or condition which would interfere with study participation or unduly increase risk. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total number of new clinically visable AKs as measured by a full skin exam performed by a blinded, board certified dermatologist (Dr. Asgari). | one year | ||
Secondary | Histologic presence of UV-induced cyclobutane pyrimidine dimer positive cells | one year | ||
Secondary | Degree of solar elastosis assessed using Verhoeff stain on biopsy specimens obtained from punch biopsy | one year | ||
Secondary | Counts of sunburnt cells in sun exposed skin | one year |
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